A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ObsEva SA
- 入组人数
- 526
- 试验地点
- 116
- 主要终点
- Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24
研究概览
简要总结
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
详细描述
The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids.
Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal woman at screening.
- •Body Mass Index ≥ 18 kg/m
- •Menstrual cycles ≥ 21 days and ≤ 40 days.
- •Presence of uterine fibroids.
- •Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.
排除标准
- •The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
- •History of uterus surgery that would interfere with the study.
- •The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided.
- •Undiagnosed abnormal uterine bleeding.
- •Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.
研究组 & 干预措施
OBE2109 dose 1 (100mg) + Placebo Add-back
干预措施: OBE2109 (Drug)
OBE2109 dose 1 (100mg) + Placebo Add-back
干预措施: Placebo to match OBE2109 (Drug)
OBE2109 dose 1 (100mg) + Placebo Add-back
干预措施: Placebo to match Add-back (Drug)
OBE2109 dose 1 (100mg) + Add-back
干预措施: OBE2109 (Drug)
OBE2109 dose 1 (100mg) + Add-back
干预措施: Placebo to match OBE2109 (Drug)
OBE2109 dose 1 (100mg) + Add-back
干预措施: Add-back (Drug)
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
干预措施: OBE2109 (Drug)
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
干预措施: Placebo to match Add-back (Drug)
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
干预措施: Add-back (Drug)
OBE2109 dose 2 (200mg) + Add-back
干预措施: OBE2109 (Drug)
OBE2109 dose 2 (200mg) + Add-back
干预措施: Add-back (Drug)
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
干预措施: OBE2109 (Drug)
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
干预措施: Placebo to match OBE2109 (Drug)
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
干预措施: Placebo to match Add-back (Drug)
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
干预措施: Add-back (Drug)
结局指标
主要结局
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24
时间窗: From baseline to Week 24
Assessed using the alkaline hematin method
次要结局
- Amenorrhea(Up to Week 52)
- Number of days of uterine bleeding for the last 28-day interval prior to Week 24(last 28-day interval prior to Week 24)
- Number of days of uterine bleeding for each 28-day interval(Up to Week 52)
- Time to reduced menstrual blood loss(Up to Week 52)
- Time to amenorrhea(Up to Week 52)